The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate Traumatic Brain Injury (TBI) Patients (DCS)
Recruitment status was: Not yet recruiting
In this study of patients with moderate traumatic brain injury with frontal brain contusions patients will be randomized to treatment with a single dose of either D-cycloserine or placebo given 48-72 hours after injury.
Patients will undergo intensive neurocognitive testing at 3 and 6 months after injury to assess whether treatment with a single dose of D-cycloserine improves cognitive outcome after moderate brain injury.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate TBI Patients|
- A battery of neuropsychological tests at 3 and 6 months post-injury [ Time Frame: 3 and 6 months post-injury ]
- Symbol Digit Modalities Test (Smith 1973)
- Trail Making Test (TMT) (Reitan, Hom et al. 1988)
- Digit Span (DS) from the WAIS-III
- Rey Auditory Verbal Learning Test (RAVLT) (Rey 1955; Lezak 2004)
- Wisconsin Card Sorting Test (WCST) (Psychological Assessment Resources. Computerised Wisconsin Card Sort Task Version 4 (WCST). Psychological Assessment Resources; 2003).
- Test of Variables of Attention (TOVA) (Test of Variables of Attention: Clinical Manual. Los Alamitos: The TOVA Company).
- Behavioral Assessment of the Dysexecutive Syndrome (BADS) (Erez, Rothschild et al. 2009)
- Glasgow Outcome Score - Extended (GOS-E) [ Time Frame: 3 and 6 months post injury ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
|Experimental: D- Cycloserine||
single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury
Other Name: seromycin
|Placebo Comparator: sugar pill||
A sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343862
|Rambam Medical Center|
|Hadassah Medical Center|
|Jerusalem, Israel, 91120|
|Sheba Medical Center|
|Ramat Gan, Israel|
|Principal Investigator:||Guy Rosenthal, MD||Hadassah Medical Center|